Standard II

Informed Consent

Ellie Halverson, Chad Paisley, Joshua Schultz

 AANA Standard II - What is it?

● “Obtain and document informed consent for the planned anesthetic

intervention from the patient or legal guardian, or verify that informed
consent has been obtained and documented by a qualified professional”

● CRNA will:
○ explain any consent questions relating to anesthesia
○ obtain consent
○ verify consent was obtained
○ Document obtained consent within the medical record
Image from: https://twitter.com/aanawebupdates
(Oakes, 2017)
 Origins of Informed Consent

Two separate theories of liability that arose through court decisions necessitated the
creation of informed consent:

1. Common Law Battery--performance of a procedure without the valid consent of

the patient. Even if the procedure was performed without negligence. This
includes unauthorized touching.

1. Negligent Failure to Warn--failure to warn the patient of potential risks that

could occur and failure to inform the patient of alternate treatment methods.

(AANA, 2017)
Schloendorff v Society of New York Hospitals
(1914)

● Mary underwent surgery to remove a tumor after only

consenting for an exam under ether anesthesia
● Justice Cardozo ruled that any human being of adult age and
sound mind shall have the right to determine what is done to
their body
○ Despite his ruling courts remained reluctant to rule against
the medical profession
(Green & MacKenzie, 2007)
 Salgo v Leland Stanford Jr. University Board
of Trustees (1957)

● Martin woke up after an aortograph and was paralyzed

● Martin claimed that he was never informed that paralysis was a
complication that could occur with the procedure
● The ruling was that failure to disclose risks and alternatives was
cause for legal action on its own accord

(Green & MacKenzie, 2007)

 Natanson v Kline (1960)

●Irma suffered disabling burns due to cobalt irradiation for breast

cancer
● Irma claimed that she had been told that there were no risks
associated with the radiation treatment
● The court ruled that the medical professional is responsible to
uphold a standard of disclosure in regards to risks that a
reasonable practitioner would provide

(Green & MacKenzie, 2007)

 Canterbury v Spence (1972)

● Jerry was partially paralyzed resulting from thoracic spine

surgery
● Jerry claimed that he had not been informed that paralysis was a
risk that existed with this type of surgery
● The surgeon testified that Jerry was correct in his claim
● The ruling on the case established that all informed consent
needed to be consistent to what a reasonable provider would
provide, not just the personal thoughts of each individual
provider
(Green & MacKenzie, 2007)
 Why is Informed Consent Important?

● Informed consent is grounded in an ethical and legal concept

○ Patients have the right to understand what is being done to their bodies
(personal autonomy) and agree to the potential consequences of the
healthcare intervention (self-determination and self-decision)

● Failure to obtain informed consent

○ Compromises patient autonomy

○ May increase patient safety risk due to
incomplete patient-clinician communication
○ May constitute negligence, battery, breach of contract, or
other legal claims, and may lead to professional discipline

(AANA, 2017)
 Elements of Informed Consent

● Autonomy

● Competence and decision making capacity

● Disclosure of information

● Understanding of disclosed information

(AANA, 2017)
 Autonomy

● Autonomy refers to a person’s

independence and implies that if a patient
refuses treatment, the healthcare team will
honor their refusal (Potter, 2011). The
form be be signed voluntarily in the
presence of a witness. The patient should
not be persuaded or coerced in any way to
undergo the procedure and should be
aware that consent can be withdrawn at
any time if the desire to give permission
changes (Lewis, 2007).
(Potter, 2011)
Competence and Decision Making Capacity
● To be competent, a patient must have legal authority to make healthcare decisions.

● In most states, patients over eighteen are considered competent unless otherwise
determined by a court (AANA, 2017).

● They must demonstrate clear understanding and comprehension of the

information being provided before receiving sedating preoperative medications
because these medications could temporarily affect their competence.

● If the patient is unconscious or mentally incompetent, written permission can be

given by a legal representative or responsible family member (Lewis, 2007).

● In an emergency, healthcare providers may provide care to a patient without

consent if there is no evidence to indicate that the patient or legal representative
would refuse treatment (Potter, 2011).
 Disclosure of Information
● There needs to be full disclosure of the procedure being discussed prior to
obtaining a signature.

● The anesthesia consent should detail the risks, benefits, and alternatives
unique to anesthesia which can be different from surgical risks.

○ When detailing the risks of anesthesia you need to detail minor

injuries like tooth damage or nausea as well as rare but severe
injuries like nerve injury or death

○ Even if the alternatives to general anesthesia are not feasible or

preferred by the physician, it’s still important to explain to patients
the thought process and involve them in the conversation.

(Pascarella, Walls, Liu, & Chen, 2014)

 Understanding of Disclosed Information

● The provider must ensure that the patient understands everything.

● When explaining the information surrounding the procedure it’s important to do it

in terms a layperson can understand (Miller, 2011).

● If the patient does not speak English, a translator should be provided.

● The patient must also be given the opportunity to ask question about the various
treatment options and have those questions answered (Lewis, 2007)
 Anesthesia Consent - Is it separate from
surgical consent?

● Traditionally, consent for anesthesia within surgery has always

been considered ‘implied’, as the surgical consent often states
that the surgery requires anesthesia and that there are risks
associated with anesthesia

● However, the surgeon is not trained to create an anesthesia

care plan, nor is he or she trained to discuss the risks, benefits,
and possible alternatives to the administration of anesthesia
services

(Singh & Sing, 2017)

 Patient Participation During Informed
Consent

Four Components to Patient ● Cegala, D., Chisolm, D., &

Participation
● Information seeking and
verifying
● Information provision
● Assertive utterances
● Expressions of affect
Nwomeh, B (2012) found
that when patients ask
questions, express opinions
on treatments, and state
preferences of care, they
have measurably better
health outcomes than
patients that do not

(Cegala & Chisolm, 2012)

 What is involved in an informed consent
discussion?

- description of the proposed plan

-mention alternatives, risks, and benefits

discussion of uncertainties

-assessment of patient comprehension

-solicitation of a preference/decision
Image from: http://informalletter.info/8-medical-consent/

(Gentry, Lepere, & Opel, 2017)

 Pediatric, Minors, and Mentally Incapable
Consent for Anesthesia

● Obtained from surrogates (parents or legal guardians)

rather than the patient
● Sought after guardians have authorized the surgical
intervention
(Gentry, Lepere, & Opel, 2017)

● Qualifications for capability to consent for children

(also called “Consent by proxy”)
○ Adult must have the right to consent
○ Legally and medically competent to consent Image from: https://www.wasatchpeds.net/

(Zimlich, 2017)

*absolute emergency, can proceed without consent

 When Informed Consent Wasn’t Followed

● Dr. asked nurse if consent had been signed

● Nurse responded yes (without checking)
● Procedure was performed on infant that no
consent was signed (and procedure was not
wanted on that infant)
● Very angry mother and low patient
satisfaction (plus hospital lost money by
Image from:

compensating infant’s stay) https://www.centerforhealthjournalism.org/2016/05/

09/3-horrific-medical-mistakes-scandalize-
profession
 References:

AANA. (2017). Informed consent for anesthesia care. Retrieved from

https://www.aana.com/docs/default-source/practice-aana-com-web-documents-(all)/informed-consent-for-anesthesia-
care.pdf?sfvrsn=8a0049b1_2

Cegala, D. J., Chisolm, D. J., & Nwomeh, B. C. (2012). Further examination of the impact of patient participation on physicians'
communication style. Patient Education and Counseling, 89, 25-30.

Gentry, K. R., Lepere, K., & Opel, D. J. (2017). Informed consent in pediatric anesthesiology. Pediatric Anesthesia, 27(12), 1253-1260.
doi:10.1111/pan.13270

Green, D. S., & MacKenzie, C. R. (2007). Nuances of informed consent: The paradigm of regional anesthesia. Retrieved November 21,
2017, from https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2504103/
Lewis, S. M. (2007). Medical-surgical nursing : assessment and management of clinical problems. St. Louis, Mo., McGraw-Hill.
 References:

Miller, R. D., et al. (2011). Basics of anesthesia. Philadelphia, PA, Elsevier/Saunders.

Oakes, J. (2017). AANA Scope of practice: Standards of nurse anesthesia practice {PowerPoint slides]

Pascarella, M. R., Walls, J. D., Liu, R., & Chen, L. (2014). Anesthesia Providers are Obligated to Give Patients the Alternatives to General Anesthesia
when Obtaining Informed Consent. Translational Perioperative and Pain Medicine, 1(2), 5–8.

Potter, P. A. (2011). Basic nursing. St. Louis, Mo., Mosby Elsevier.

Singh, T. S. S. (2017). Is it time to separate consent for anesthesia from consent for surgery? Journal of Anaesthesiology, Clinical Pharmacology,
33(1),
112–113. http://doi.org/10.4103/0970-9185.202206

ZIMLICH, R. (2017). What is 'consent by proxy' for medical care?. Contemporary Pediatrics, 34(4), 27-29.